HydroVax-001B Vaccine for West Nile Virus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find a safe and effective vaccine to prevent West Nile virus infection, a disease spread by mosquito bites. Researchers are testing different doses of the HydroVax-001B vaccine to evaluate its efficacy and monitor for any side effects. Participants will receive either the vaccine or a placebo (a harmless inactive substance) and must be healthy adults who have never had a flavivirus infection or vaccine. This study is ideal for those in good health without recent serious medical issues.
As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, if you have started a new prescription medication within 30 days of enrollment, it may affect your eligibility unless it's in the same class or a brand/generic switch. Also, certain medications that could pose a risk or interfere with the study might require adjustment.
Is there any evidence suggesting that the HydroVax-001B WNV vaccine is likely to be safe for humans?
Research has shown that the HydroVax-001 vaccine, similar to HydroVax-001B, is safe and well-tolerated in previous studies. These studies reported no serious side effects at the 1 mcg dose, indicating that the vaccine does not cause major side effects at lower doses. The current trial, in its early stages, aims to assess the safety of HydroVax-001B at higher doses of 4 mcg and 10 mcg to ensure it remains safe for participants.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about the HydroVax-001B vaccine for West Nile Virus because it introduces a potentially powerful new way to prevent the disease. Unlike current treatments, which primarily focus on managing symptoms or providing supportive care, HydroVax-001B aims to protect against the virus itself through immunization. This vaccine uses a novel formulation that could offer better protection with both low and high dose options. The ability to administer it intramuscularly at specific intervals (Day 1, Day 29, and Day 181) may also enhance its effectiveness and convenience compared to existing options.
What evidence suggests that the HydroVax-001B WNV vaccine might be an effective treatment for West Nile Virus?
Research shows that the HydroVax-001B vaccine for West Nile Virus (WNV) effectively creates a strong immune response. It helps the body produce antibodies that fight infections, particularly effective against certain virus strains. Studies have found that the vaccine is well-tolerated, meaning it does not cause serious side effects. Early results suggest that the vaccine could play a crucial role in preventing WNV infections and reducing related health problems. Overall, these findings indicate that HydroVax-001B is a promising option for protection against West Nile Virus.16789
Are You a Good Fit for This Trial?
Healthy adults aged 18-49 who can follow the study plan and attend all visits. They must consent to blood collection and not be pregnant or breastfeeding. Those with previous flavivirus infections, vaccinations, or likely exposure are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the HydroVax-001B WNV vaccine or placebo on Days 1, 29, and 181
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for serious adverse events and immunogenicity
What Are the Treatments Tested in This Trial?
Interventions
- HydroVax-001B WNV
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor